FDA: ReGen's knee device should not have been approved

ReGen Biologics Inc.’s orthopedic knee device shouldn’t have been cleared for marketing in 2008, U.S. regulators said after a one-year investigation into complaints that political pressure led to the decision.

The Food and Drug Administration will begin the process of rescinding approval of the device and meet with the company to determine what data would be needed before its re-introduction to the market, the agency said today in a statement. It’s “unlikely” that patients who have already received the device will need to have it removed, the FDA said.

Senator Charles Grassley, an Iowa Republican, had urged the FDA to reconsider the December 2008 approval after reports that the Hackensack-based company and lobbying from state lawmakers influenced the agency. The FDA said in September 2009 that its decision was “flawed” and would be reviewed.

The agency concluded that ReGen’s Menaflex device wasn’t substantially similar to an existing product and shouldn’t have been cleared under an expedited process that generally doesn’t require clinical studies in people, the FDA said in its statement.

Menaflex is a collagen scaffold used in surgery to fix a torn medial meniscus, the most common form of knee injury. The scaffold reinforces and repairs damaged tissue.

ReGen “is currently weighing its options” about Menaflex, said Gerald E. Bisbee Jr., the company’s chief executive officer and chairman, in an e-mail. “The product has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.”